Rheumatology Unit, Meyer Children's University Hospital.
Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence.
Rheumatology (Oxford). 2022 Apr 11;61(4):1518-1528. doi: 10.1093/rheumatology/keab572.
Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting.
This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.
A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE).
Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA.
有关生物类似药（BIOs）在幼年特发性关节炎（JIA）儿童中的使用数据有限。因此，本研究旨在评估在真实环境中，JIA 儿童从依那西普（ETA）和阿达木单抗（ADA）原研药转换为生物类似药（BIOs）后的长期疗效和安全性。
这是一项回顾性前瞻性非干预性多中心意大利比较队列研究。纳入接受 ETA 或 ADA 生物类似药治疗的 JIA 儿童的病历。在原研药和转换为生物类似药后 3、6 和 12 个月的最后一次随访时，评估 TNF 抑制剂治疗的疗效和安全性。
共纳入 59 名儿童（42 名女性，发病中位年龄 88 个月），其中 21 名接受 ETA 生物类似药治疗，38 名接受 ADA 生物类似药治疗。45 名患者从原研药转换为生物类似药（17 名 ETA，28 名 ADA）。转换时，17 名 ETA 和 28 名 ADA 中有 12 名患者处于缓解状态。转换后 3、6 和 12 个月时，未发现显著差异。10 名患者因疾病缓解（4 名 ETA，3 名 ADA）、家庭意愿（1 名 ETA）、注射部位烧灼感（1 名 ETA）和持续活动（1 名 ADA）而停用生物类似药。在达到疾病缓解的时间、复发时间和发生不良反应（AE）的患者数量方面，原研药与生物类似药之间、原研药与生物类似药之间、ADA 与 ETA 之间均未观察到统计学显著差异。
我们的真实世界研究结果似乎证实了从 ADA 和 ETA 的原研药转换为各自的 BIOs 在 JIA 儿科患者中的疗效和安全性。
